RG6640 / Roche - LARVOL DELTA

Enith2: A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes (clinicaltrials.gov) - P3 | N=1600 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Enith1: A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes (clinicaltrials.gov) - P3 | N=2000 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

BP46585: A study investigating the safety, absorption, and elimination of RO7795068, a new compound that may potentially be used in the treatment of obesity (clinicaltrialsregister.eu) - P1 | N=26 | Not yet recruiting | Sponsor: F. Hoffmann-La Roche AG

New P1 trial • Genetic Disorders • Obesity

Enith2: A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes (clinicaltrials.gov) - P3 | N=1600 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Enith1: A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes (clinicaltrials.gov) - P3 | N=2000 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Genentech Announces Positive Phase II Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People Living With Obesity (Businesswire) - "The study found that once-weekly subcutaneous injections of CT-388 (titrated up to 24 mg) resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks. A clear dose-response relationship on the weight loss was observed. For the treatment-regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3% (p-value < 0.001)....The full results of the study will be presented at an upcoming medical congress."

P2 data • Obesity

The Phase III clinical trial program of CT-388 in obesity (Enith1 and Enith2) is expected to start this quarter (Businesswire)

Trial status • Obesity • Type 2 Diabetes Mellitus

A Study of CT-388 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity (clinicaltrials.gov) - P2 | N=469 | Completed | Sponsor: Carmot Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Effects of CT-388, a once-weekly signaling-biased dual GLP-1/GIP receptor agonist, on weight loss and glycemic control in preclinical models and participants with obesity. (PubMed, Mol Metab) - P1 | "In clinical settings, 4 weeks of CT-388 treatment produced clinically meaningful weight loss and improved glycemic control with favorable tolerability. These findings warrant further clinical evaluation of CT-388 for treating obesity and type 2 diabetes."

Journal • Preclinical • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

Effect of CT-388 on Glucose Tolerance in Adults With Obesity With or Without Type 2 Diabetes (OBESITY WEEK 2025) - P1 | "All pts in C3 were on a stable dose of metformin for ≥3 months.At Day -1, OGTT glucose and insulin excursions were similar between pbo and CT-388 in all 3 cohorts. CT-388 improved glucose tolerance as early as Week 6 and this was sustained to Week 12, most noticeably in pts with obesity and T2D but also in pts with obesity without T2D. These findings support continued investigation of CT-388 in longer-term trials in pts with obesity with and without T2D."

Clinical • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effect of CT-388 on Liver Fat in Adults with Obesity, With or Without Type 2 Diabetes (OBESITY WEEK 2025) - P1 | "In this phase 1 trial, CT-388 treatment was associated with clinically meaningful reductions in LFC in pts with obesity, with or w/o T2D. After 12 weeks of CT-388 treatment, pts with LFC ≥5% at BL, indicative of metabolic dysfunction-associated steatotic liver disease (MASLD), experienced median LFC reductions of 50%–60%, and most of these pts achieved target LFC reductions of ≥30%. Together with previously reported weight loss and glycemic control improvements for CT-388 treatment, these data suggest enhancements in metabolic health."

Clinical • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Chugai In-Licenses GLP-1/GIP Receptor Agonist CT-388 (Chugai Press Release) - "Chugai obtained exclusive development and marketing rights in Japan for CT-388, a long-acting GLP-1/GIP receptor agonist under development for obesity and type 2 diabetes, from Roche....Roche will receive an upfront fee and milestone payments."

Licensing / partnership • Diabetes • Obesity

A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

'We have the will': Roche unveils strategy to become 'top 3' obesity company (FierceBiotech) - "...CT-388—into a phase 3 study in the first half of next year....The company is eyeing peak sales of more than $3 billion for both CT-388 and petrelintide, according to Roche’s presentation"."

New P3 trial • Sales projection • Obesity

Upcoming events next 12 months (GlobeNewswire) - "In the first half of 2026, Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-1 trial and complete the Phase 2 ZUPREME-2 trial with petrelintide...Zealand Pharma and Roche expect to initiate Phase 2 trials with petrelintide/CT-388 in the first half of 2026...In the second quarter of 2025, Zealand Pharma expects to announce topline results from Part 2 of the Phase 1b trial evaluating higher doses of dapiglutide over 28 weeks of treatment, with subsequent initiation of a Phase 2 trial expected in the second half of 2025. Zealand Pharma will present the results from Part 1 of the Phase 1b trial at the American Diabetes Association’s 85th Scientific Sessions in Chicago, Illinois in June 2025....Topline data from SYNCHRONIZE-1 and SYNCHRONIZE-2, the Phase 3 trials with survodutide in participants with overweight or obesity without and with type 2 diabetes, respectively, are expected in the first half of 2026."

Clinical data • New P2 trial • Trial status • Obesity • Type 2 Diabetes Mellitus

Glycemic Control, Weight Reduction, and Safety with CT-388, a Signal-Biased Dual GLP-1/GIP Receptor Agonist—Results from a 12-Week Cohort in Adults with Obesity and Type 2 Diabetes (ADA 2025) - P1, P2 | "Here, we present safety, tolerability, and pharmacodynamic results from an additional cohort of adults with obesity and T2D. Adults with obesity and T2D (n=19) treated with diet/exercise alone or with metformin, and HbA1c 7.0%−10.0% at baseline (BL) were randomized (4:1) to either once-weekly subcutaneous CT-388 22 mg or pbo over 12 weeks. In a T2D cohort with obesity, CT-388 led to clinically meaningful improvements in glycemic control, including normalizing dysglycemia, and WL over 12 weeks. Safety/tolerability were in line with incretin-based therapies in similar stages of development. A phase 2 study of CT-388 in pts with T2D has been initiated (NCT06628362)."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effect of CT-388, a Signal-Biased Dual GLP-1/GIP Receptor Agonist, on Liver-Related MRI Parameters in Patients with Obesity (ADA 2025) - P1 | "In this phase 1 study, CT-388 showed clinically meaningful reductions in liver fat and inflammation in pts with obesity and MAFLD."

Clinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Carmot Therapeutics, Inc. | Trial completion date: May 2026 ➔ Nov 2026

Trial completion date • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Zealand Pharma and Roche enter collaboration and license agreement to co-develop and co-commercialize petrelintide as a future foundational therapy for people with overweight and obesity (GlobeNewswire) - "Zealand Pharma...announces a global collaboration and license agreement with Roche...to develop petrelintide, Zealand Pharma’s amylin analog with best-in-class potential, as a foundational therapy for weight management, while rapidly expanding into related indications. The two companies will co-develop and co-commercialize petrelintide and combination products with petrelintide, including a fixed-dose combination product of petrelintide and CT-388, Roche’s lead incretin asset and potential best-in-class GLP-1/GIP receptor dual agonist....As part of this agreement, Zealand Pharma will receive upfront cash payments of USD 1.65 billion, including USD 1.4 billion due upon closing and USD 250 million over the first two anniversaries of the collaboration. Zealand Pharma is also eligible for development milestones of USD 1.2 billion, primarily linked to initiation of Phase 3 trials with petrelintide monotherapy, and sales-based milestones of USD 2.4 billion..."

Licensing / partnership • Obesity

Roche enters into an exclusive collaboration & licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity (GlobeNewswire) - "Roche...announced today that it has entered into an exclusive collaboration and licensing agreement with Zealand Pharma (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078). Under the terms of this agreement, the two companies will collaborate to co-develop and co-commercialise petrelintide, Zealand Pharma’s amylin analog as a standalone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388....Under the terms of the agreement, Zealand Pharma will receive upfront cash payments of USD 1.65 billion, including USD 1.4 billion due upon closing and USD 250 million over the first two anniversaries of the collaboration."

Licensing / partnership • Obesity

A Study of CT-388 in Participants with Obesity or Overweight with At Least One Weight-Related Comorbidity (clinicaltrials.gov) - P2 | N=450 | Active, not recruiting | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study of CT-388 in Participants Who Are Overweight or Obese with Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: Carmot Therapeutics, Inc.

New P2 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of CT-388 in Participants Who Are Overweight or Obese with Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Carmot Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=130 | Completed | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Completed | N=96 ➔ 130 | Trial completion date: Oct 2023 ➔ Aug 2024 | Trial primary completion date: Sep 2023 ➔ Jun 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Safety, pharmacokinetics, and pharmacodynamics of CT-388, a signal-biased dual GLP-1/GIP receptor agonist, over 24 weeks in adults with obesity (EASD 2024) - P1 | "CT-388 was safe and tolerable, with no treatment-related discontinuations over 24w despite a rapid and steep up-titration to 22 mg, and delivered clinically meaningful WL and metabolic control in otherwise healthy adults with obesity. These data warrant further clinical evaluation of CT-388 for the treatment of obesity and obesity-related comorbidities, such as T2D."

Clinical • Late-breaking abstract • PK/PD data • Metabolic Disorders • Obesity